Medical-biological Research of the Pathogenesis of COVID-19 Disease Caused by SARS-CoV-2 (COV2020)

Federal Research and Clinical Center of Physical-Chemical Medicine

Status: Unknown

Conditions: Covid19

Study type: Observational

Funder types: Other

Identifiers

NCT04611841

COV2020

Details and patient eligibility

About

Сonducting in-depth medical and biological studies of the pathogenesis of the disease caused by the SARS-CoV-2 in Moscow, the Moscow region and some other regions of the Russian Federation.

Full description

To date, none of the methods used to test for coronavirus infection provide reliable information about the status of an individual's infection. Common tests based on PCR, carried out on the basis of samples taken from the human respiratory tract, give a positive answer in far from all cases. Antibody tests may not record the initial stages of the disease, or may not reveal residual immunity in those who have been ill, while giving cross-reactions to other common coronaviruses.

A comprehensive assessment of the biological parameters of the virus and the parameters of the immune response to infection is required. In this regard, we propose an integrated approach, including the use of PCR testing technology, analysis of the immune response in the form of antibodies of all major classes (IgG, IgA), determination of inflammation markers, C-reactive protein, detailed blood test, ferritin and troponin.

In addition, an analysis of the genetic diversity of strains of the pathogen COVID-19 circulating among various groups of the population of the Russian Federation will be carried out.

To collect and analyze data, it is planned to enter information into a special electronic system and analyze the collected data with a wide range of informative methods that allow "layer by layer" to compare and collect a complete picture of what is happening.

Objectives of the study:

1. Identifying the percentage of infected in the population in Moscow, the Moscow region and some other regions where the epidemic situation in connection with SARS-CoV-2 remains tense;
2. Study of genetic diversity (including metavirome) and dynamics of structural variability of the causative agent of coronavirus infection in the studied regions;
3. Studying the features of the formation and tension of immunity in patients who have undergone coronavirus infection of varying severity;
4. Clarification of the mechanisms of occurrence and development of coronavirus infection.

In the study of biological samples obtained from research participants, methods of proteomics, peptidomics, next generation sequencing (NGS), physicochemical methods of analysis will be used.

Enrollment: 250 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age over 18 and under 75 years old
• COVID-19 diagnosis confirmed by PCR test
• Written consent to participate in the study

Exclusion criteria

• Unwillingness or inability to give written informed consent to participate in the study
• A serious condition with a threat to life or contraindications that prevent the collection of biomaterial
• Oncological diseases outside the stage of remission